Endoluminal drug delivery devices and methods

ABSTRACT

A device and method for delivering a drug from inside a body lumen to tissue surrounding the body lumen. An endoluminal drug delivery device includes a dual-lumen catheter for housing a guidewire and a needle connectable to a drug source. The guidewire exits the catheter through an opening at the distal end, and the needle exits the catheter through an exit port in the outer wall of the catheter. A distal portion of the catheter has a single lumen and includes a taper, allowing the distal tip to act as a dilator. The device optionally includes a catheter lumen splitter and/or a handpiece assembly. A method of delivering fluid to tissue surrounding a body lumen includes inserting a guidewire into the body lumen, tracking the device over the guidewire, deploying the needle through the exit port to the tissue, delivering fluid, and retracting the needle into the catheter.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/162,426, filed Jun. 16, 2011, which is incorporated by referenceherein in its entirety.

BACKGROUND

2. Field

The present application generally relates to devices and methods fordelivering medicinal substances to an area surrounding a vein.

2. Description of the Related Art

Normally, valves in veins keep blood moving toward the heart and preventbackflow. In patients with varicose veins, the valves do not functionproperly, so blood flows back toward the patient's extremities and poolsin the veins. This can lead to skin necrosis. Laser or RF ablationtreatment creates hypercoagulability to close the abnormal vein, whichis subsequently absorbed by the body. The current commonly-used methodof delivering numbing medication to the treatment area prior to theablation procedure requires multiple injections in the patient's thigh,each through the skin. Disadvantages of this method can include pain forthe patient and inefficiency.

SUMMARY

The devices and methods described herein can use only a single puncturethrough the patient's skin to deliver multiple injections of a drug frominside a body lumen, such as a vein, to the tissue surrounding the bodylumen. The endoluminal drug delivery device includes a flexible catheterwith two lumens—a first lumen for a guidewire and a second lumen for aneedle. The guidewire exits the catheter through an opening at thedistal end, and the needle exits the catheter through an exit port inthe catheter wall. The first lumen and guidewire can span the length ofthe catheter or only a distal portion of the catheter. The second lumenends at the exit port, so the section of the catheter distal to the exitport has only one lumen and serves as a dilator. The catheter can havemultiple exit ports along its length. A distal portion of the cathetercan be tapered, and the exit port can be on the straight portion of thecatheter or on the tapered portion. The second lumen houses a needleincluding a shape-memory material, such as nitinol, that is shape-set tohave a curved distal portion. The needle straightens when inside thecatheter, but when pushed forward in the catheter, the needle isconfigured to bias away from the second lumen and out of the exit portand assumes its curved shape. The catheter can split into twosingle-lumen portions at the proximal end of the catheter, and thedevice can have an optional lumen splitter to provide strength at thejoint where the catheter splits. The device can also have an optionalhandpiece assembly with a button used to move the needle. The needle canbe connected to a drug delivery system having a drug source. To use thedevice, the guidewire is inserted into a body lumen, such as a vein,through the patient's skin and the device is tracked over the guidewireby using the section of the catheter distal to the needle exit port as adilator. Once the catheter is in position, the needle is pushed forwardso that it exits the catheter through the exit port, pierces the bodylumen wall, and enters the tissue surrounding the body lumen. The drugis delivered to the tissue from the drug source and delivery system, andthen the needle is retracted back into the catheter. The device can thenbe further tracked over the guidewire to a different position, and theprocess can be repeated as desired.

In some embodiments, an endoluminal drug delivery device comprises aflexible catheter. The flexible catheter has a proximal end and a distalend. The device further comprises a first lumen extending from theproximal end to the distal end, a second lumen extending between theproximal end and an exit port, and a needle. The first lumen is adaptedto house a guidewire. A section of the catheter distal to the exit portis self-dilating. The needle is configured to bias out of the exit portand away from the second lumen when the needle is longitudinallydistally advanced. The needle includes a needle lumen configured to bein fluid communication with a drug delivery system.

In some embodiments, a method of delivering a fluid to tissuesurrounding a body lumen having a wall comprises percutaneouslyinserting a guidewire into the body lumen through the wall and insertinga distal end of an endoluminal drug delivery device into the body lumenby tracking a first lumen of the device over the guidewire. The deviceincludes a catheter having a proximal and a distal end. The first lumenextends from the proximal end to the distal end. The device furtherincludes a second lumen extending between the proximal end and an exitport and a needle. A section of the catheter distal to the exit port isself-dilating during tracking The needle is configured to bias away fromthe second lumen and out of the exit port when the needle islongitudinally distally advanced. When the exit port is in a firstposition, the needle is advanced out of the second lumen through theexit port. The method further comprises advancing the needle through thewall to the tissue, delivering fluid to the tissue through the needle,and retracting the needle into the catheter.

In some embodiments, a method of manufacturing an endoluminal drugdelivery device comprises inserting a needle into a second lumen of acatheter. The catheter includes a first lumen extending from a proximalend to a distal end and is configured to house a guidewire and thesecond lumen extending between the proximal end and an exit port. Asection of the catheter distal to the exit port is self-dilating. Theneedle is configured to bias out of the exit port and away from thesecond lumen when the needle is longitudinally distally advanced. Theneedle includes a needle lumen configured to be in fluid communicationwith a drug delivery system.

For purposes of summarizing the disclosure and the advantages achievedover the prior art, certain objects and advantages are described herein.Of course, it is to be understood that not necessarily all such objectsor advantages need to be achieved in accordance with any particularembodiment. Thus, for example, those skilled in the art will recognizethat the disclosure may be embodied or carried out in a manner thatachieves or optimizes one advantage or group of advantages as taught orsuggested herein without necessarily achieving other objects oradvantages as may be taught or suggested herein.

All of these embodiments are intended to be within the scope of thedisclosure herein. These and other embodiments will become readilyapparent to those skilled in the art from the following detaileddescription having reference to the attached figures, the disclosure notbeing limited to any particular disclosed embodiment(s).

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presentdisclosure are described with reference to the drawings of certainembodiments, which are intended to schematically illustrate certainembodiments and not to limit the invention.

FIG. 1 is a top and side perspective view of an example embodiment of anendoluminal drug delivery device;

FIG. 2 is an example embodiment of a transverse cross-sectional view ofthe endoluminal drug delivery device of FIG. 1 along the line 2-2 inFIG. 1;

FIG. 3A is a top and side perspective view of an example embodiment of adistal portion of an endoluminal drug delivery device;

FIG. 3B is a longitudinal cross-sectional view of the distal portion ofthe endoluminal drug delivery device of FIG. 3A;

FIG. 3C is a longitudinal cross-sectional view of another exampleembodiment of a distal portion of an endoluminal drug delivery device;

FIG. 3D is an a longitudinal cross-sectional view of another exampleembodiment of a distal portion of an endoluminal drug delivery device;

FIG. 4 is a side elevational view of an example embodiment of the distalportion of a needle;

FIG. 5A is a longitudinal cross-sectional view of an example embodimentof a catheter lumen splitter including a portion enlarged for clarity;

FIG. 5B is a longitudinal cross-sectional view of another exampleembodiment of a catheter lumen splitter including two portions enlargedfor clarity;

FIG. 6A is an exploded top and side perspective view an exampleembodiment of a handpiece assembly;

FIG. 6B is a longitudinal cross-sectional view of the assembledhandpiece assembly of FIG. 6A;

FIGS. 7A and 7B show an example embodiment of a drug delivery system;

FIG. 8 shows an example embodiment of a method of delivering a fluid totissue surrounding a body lumen using an endoluminal drug deliverydevice.

DETAILED DESCRIPTION

Although certain embodiments and examples are described below, those ofskill in the art will appreciate that the disclosure extends beyond thespecifically disclosed embodiments and/or uses and obvious modificationsand equivalents thereof. Thus, it is intended that the scope of thedisclosure herein disclosed should not be limited by any particularembodiments described below.

FIG. 1 illustrates an example embodiment of an endoluminal drug deliverydevice 100. FIG. 2 is an example embodiment of a transversecross-sectional view of the device 100 of FIG. 1 along the line 2-2 inFIG. 1. The device 100 comprises a flexible catheter 102, a first lumen316, a second lumen 318, and a needle 104. The flexible catheter 102 hasa proximal end 115 and a distal end 116. The first lumen 316 extendsfrom the proximal end 115 to the distal end 116. The first lumen 316 isconfigured to house a guidewire. The second lumen 318 extends betweenthe proximal end 115 and an exit port 106. A section of the catheter 102distal to the exit port 106 is self-dilating. The needle 104 isconfigured to bias out of the exit port 106 and away from the secondlumen 318 when the needle 104 is longitudinally distally advanced. Theneedle 104 includes a needle lumen 320 configured to be in fluidcommunication with a drug delivery system. The guidewire exits thecatheter 102 through an opening 112 at the distal end 116. In someembodiments, the device 100 comprises an optional catheter lumensplitter 108 and/or an optional handpiece assembly 120. The device 100can be used, for example, to deliver a fluid such as a drug to tissuesurrounding a blood vessel as described in greater detail herein.

In some embodiments, the catheter 102 has a length between about 45 cmand about 55 cm. Other lengths are also possible, for example based onneedle size, guidewire size, intended use in different vasculature, fordifferent patient sizes, etc. In some embodiments, the cross-sectionaldiameter of the catheter 102 is between about 0.090 inches (in.) andabout 0.105 in. (approx. between about 0.23 centimeters (cm) and about0.27 cm). Other diameters are also possible, for example based on needlesize, guidewire size, intended use in different vasculature, fordifferent patient sizes, etc. Other transverse cross-sectional profilesof the catheter are also possible (e.g., oblong, oval, egg-shaped,polygonal, etc.). The catheter 102 may comprise a flexible material soas to be maneuverable within a body lumen as described herein. Forexample, in some embodiments, the catheter 102 comprises a polymer(e.g., polyethylene). Other materials are also possible. The catheter102 can be manufactured, for example, by extrusion, injection molding,or another suitable process.

FIG. 2 illustrates an embodiment in which the two lumens 316, 318 withinthe catheter 102 are in a parallel configuration. As described herein,the first lumen 316 is configured to house a guidewire, and the secondlumen 318 is configured to house a needle 104. In some embodiments, thesecond lumen 318 houses a guide tube 314 between the lumen 318 wall andthe needle 104, as shown in FIG. 2 and described in greater detailherein. In some embodiments, the first lumen 316 and the second lumen318 have approximately the same diameter. In some embodiments, the firstand second lumens have different diameters. The diameter of each lumen316, 318 can be, for example, between about 0.025 in. and about 0.05 in.(approx. between about 0.064 cm and about 0.13 cm), between about 0.035in. and about 0.045 in. (approx. between about 0.089 cm and about 0.11cm) (e.g., about 0.039 in. (approx. about 0.099 cm)), combinationsthereof, and the like. In some embodiments, the two lumens 316, 318within the catheter 102 are in a different configuration. For example,the second lumen 318 can be oval or oblong to allow the needle 104 toflex within the lumen 318. For another example, the first lumen 316 andthe second lumen 318 can both be oblong. For another example, at leastone of the first lumen 316 and the second lumen 318 can becrescent-shaped. For still another example, the first lumen 316 and thesecond lumen 318 can be spaced semicircles. A wide variety of lumenconfigurations and shapes are possible, and the shapes of the lumensneed not correspond to the shapes of the elements that the lumens areconfigured to contain.

FIG. 3A illustrates an example embodiment of a distal portion 200 of thecatheter 102 of the device 100. In some embodiments, the exit port 106is proximate to the distal end 116 of the catheter 102. For example, theexit port 106 can be between about 0.6 in. and about 0.7 in. (approx.between about 1.5 cm and about 1.8 cm) from the distal end 116 of thecatheter 102. Other distances of the exit port 106 from the distal end116 are also possible, for example based on dilator length, taperportion angle if applicable, etc. In some embodiments, the exit port 106has a length between about 0.20 in. and about 0.25 in. (approx. betweenabout 0.51 cm and about 0.64 cm) and a width between about 0.029 in. andabout 0.39 in. (approx. between about 0.073 cm and about 0.099 cm).Other exit port 106 dimensions are also possible, for example based oncatheter size, needle size, etc.

FIG. 3B is a longitudinal cross-sectional view of the distal portion 200of the catheter 102 of FIG. 3A. Because the second lumen 318 of thecatheter 102 terminates at the exit port 106 proximal to the distal end116 of the catheter 102, a single-lumen section 218 of the catheter 102distal to the exit port 106 only contains the first lumen 316. In someembodiments, the single-lumen section 218 of the catheter 102 has alength from the distal edge of the exit port 106 to the distal end 116of the catheter 102 of between about 0.5 in. and about 0.675 in.(between approx. 1.27 cm and about 1.72 cm). Other single-lumen section218 lengths are also possible, for example based on dilator length,taper portion angle if applicable, etc. In some embodiments, the distalportion 200 of the catheter 102 includes a taper toward the distal end116 (e.g., the outer diameter of the catheter 102 decreases fromproximal to distal). In some embodiments, as illustrated in FIGS. 3A and3B, a tapered portion 214 of the catheter 102 begins distal to the exitport 106, so the exit port 106 is on a straight side of the catheter102. In some embodiments, the tapered portion 214 begins proximal to theexit port 106, so the exit port 106 is on the tapered portion 214 of thecatheter 102, for example as illustrated in FIG. 3D. The single-lumen316 housing a guidewire makes the section 218 of the catheter 102 distalto the exit port 106 sufficiently stiff so as to be pushable and allowsthe catheter 102 to follow the guidewire. The section 218 of thecatheter 102 distal to the exit port 106 effectively serves as adilator, making the catheter 102 self-dilating. In some embodiments,tapered features help guide the catheter 102 as the catheter 102 istracked over the guidewire, contributing to the self-dilating nature ofthe catheter 102. Other shapes may also make the section 218 of thecatheter 102 distal to the exit port 106 self-dilating.

FIG. 3C illustrates an embodiment of a distal portion 202 of theendoluminal drug delivery device 100 in which the catheter 102 includesa plurality of exit ports 106 a, 106 b. The needle 104 can be deployedfrom any of the exit ports 106 a, 106 b, depending on the position ofthe needle 104 within the catheter 102. In the embodiment illustrated inFIG. 3C, the exit port 106 a is proximate to the distal end 116 of thecatheter 102. In some embodiments, the distal tip of the needle 104 isinitially between the most distal exit port 106 a and the second exitport 106 b proximal to the distal end 116 of the catheter 102. In someembodiments, the needle 104 can be longitudinally distally advanced toexit the most distal exit port 106 a, after which the needle 104 can belongitudinally proximally advanced proximal to the exit port 106 b, andthen longitudinally distally advanced to exit the exit port 106 b, andso on for any number of exit ports 106 n (not shown) consecutively fromdistal to proximal. In certain such embodiments, the needle 104 can beused to make a plurality of injections at different longitudinalpositions without movement of the guidewire 102. In some embodiments,the guidewire 102 is anchored in the vessel during movement of theneedle 104. In some embodiments in which the needle 104 is rotatablewithin the catheter 102, the needle 104 can be rotated to bias away fromthe exit ports 106 a, 106 b (e.g., 180° or at least enough to not biasout of the exit ports 106 a, 106 b) during longitudinal movement whenthe needle 104 is not to exit the exit ports 106 a, 106 b, and can berotated towards the exit ports 106 a, 106 b, and so on to exit port 106n (not shown). Combinations of the methods described herein are alsopossible. Although the exit ports 106 a, 106 b are illustrated in FIG.3C as being circumferentially aligned, other circumferentialarrangements are also possible.

FIG. 3D schematically illustrates an embodiment of a distal portion 204of the endoluminal drug delivery device 100 in which the first lumen 316extends from an opening 322 in the outer wall of the catheter 102 at aposition proximal to the distal end 116 of the catheter 102 (e.g., fromabout 8 cm proximal to the distal end 116) to the distal end 116 of thecatheter 102 in a so-called “rapid-exchange” configuration. In someembodiments, for example as illustrated in FIG. 3D, the first lumen 316and second lumen 318 overlap so that a portion of the catheter 102comprises both of the lumens 316, 318. The length of the overlappingportion can vary. In some embodiments, the first lumen 316 and secondlumen 318 do not overlap within the catheter 102. In certain suchembodiments, the catheter 102 has a smaller cross-sectional profile. Thefirst lumen 316 has an opening 112 at the distal end 116 of the catheter102. A guidewire 950 enters the first lumen 316 through the opening 112at the distal end 116 of the catheter 102 and exits the catheter 102through the opening 322 in the catheter 102. The guidewire 950 extendsexterior to and alongside the catheter 102 proximal to the opening 322in the catheter 102. In some embodiments, for example as illustrated inFIG. 3D, the opening 322 is along a straight portion of the catheter 102proximal to the tapered portion 214. In some embodiments, the opening322 is along the tapered portion 214 or the taper-straight junction.

FIG. 3D also schematically illustrates an embodiment of a distal portion204 of the endoluminal drug delivery device 100 in which the exit port106 is along the tapered portion 214. The second lumen 318 and theoptional guide tube 314 are straight, and the needle 104 only curvesonce the distal portion has exited the exit port 106. Certain suchembodiments may advantageously simplify manufacturing, for examplebecause the guide tube 314 does not include a Tuohy-style tip and/orbecause the second lumen 318 is a bore. The needle 104 may bias whenextended out of the exit port 106 without a deflection surface. In someembodiments, a distal portion 204 in which the exit port 106 is on thetapered portion does not include a guide tube, for example because theneedle 104 does not distally extend towards a portion of the catheter102.

In some embodiments (e.g., as described with respect to FIGS. 3B and3C), the tapered portion 214 of the catheter 102 terminates distal tothe exit port 106, so the exit port 106 is on a straight side of thecatheter 102 in combination with a rapid-exchange guidewireconfiguration. FIG. 3D is schematic, and the relative dimensions,positions, angles, etc. therein may be modified to suit a desiredconfiguration. For example, the length and angle of the tapered portion214 can vary, the shape of the first lumen 316 can vary, etc. Otherdistal sections of the catheter 102 are also possible, includingcombinations of embodiments described herein and otherwise.

FIG. 4 shows an example embodiment of a distal portion of the needle104. In some embodiments, the needle 104 comprises (e.g., is made of) ashape-memory material, for example, nitinol. In certain embodiments, theneedle 104 is shape-set so that the distal portion is curved when theneedle 104 is not restrained (e.g., within the second lumen 318 of thecatheter 102, within the guide tube 314, etc.). The distal portion ofthe needle 104 may be substantially straight when the needle 104 isconfined in the second lumen 318 of the catheter 102. When unrestrained,the curve of the distal portion of the needle 104 can have a radius ofcurvature between about 0.45 in. and about 0.55 in. (approx. betweenabout 1.14 cm to about 1.40 cm). Other radii of curvature and distalportion shapes of the needle 104 are also possible, for example based ondimensions of the catheter 102, the vasculature, the patient, etc. Theneedle 104 can have an inner cross-sectional diameter between about0.015 in. and about 0.025 in. (approx. between about 0.038 cm and about0.064 cm) and an outer cross-sectional diameter between about 0.02 in.and about 0.03 in. (approx. between about 0.05 cm and about 0.08 cm),and can have a length between about 20 in. and about 30 in. (approx.between about 50 cm and about 76 cm). Other dimensions of the needle 104are also possible, for example based on dimensions of the catheter 102,the vasculature, the patient, etc.

When the distal end of the needle 104 exits the exit port 106 of thecatheter 102, for example as shown in FIG. 3A, the distal end of theneedle 104 self-assumes a curved shape without requiring influence, forexample, from a deflection surface in the second lumen 318. The needle104 is thereby configured to bias out of the exit port 106 and away fromthe catheter 102 when the needle 104 is longitudinally distally advancedwithin the second lumen 318. In some embodiments, the catheter 102comprises a deflection surface (e.g., a surface of the guide tube 314 orother surface). In certain such embodiments, the deflection surfacecomprises a planar surface, a curved surface, combinations thereof, andthe like. Although the needle 104 is configured to bias out of the exitport 106 without a deflection surface, a deflection surface may help toprotect interior surfaces of the catheter 102 from the tip of the needle104, may help guide a rotatable needle 104 to the exit port 106, etc.Referring again to FIG. 4, in some embodiments, in an unrestrainedstate, the distal tip of the needle 104 is spaced from a longitudinalaxis defined by a straight portion of the needle 104 on the side of theneedle 104 opposite the curve by a distance x of between about 0.35 in.and about 0.40 in. (approx. between about 0.89 cm and about 1.02 cm).Other distances x are also possible, for example depending on the sizeof the needle 104, the relative sizes of the vasculature and thecatheter 102, etc.

The distal tip of the needle 104 is configured to pierce the vein walland surrounding tissue. In some embodiments, the distal tip of theneedle 104 has a bevel angle α between about 10° and about 30°, betweenabout 15° and about 25° (e.g., about 20°), combinations thereof, and thelike. Other bevel angles α are also possible. In some embodiments, thedistal tip of the needle 104 has a conical or pencil point tip. Incertain such embodiments, the distal tip of the needle 104 has a coneangle between about 10° and about 30°, between about 15° and about 25°(e.g., about 20°), combinations thereof, and the like. Other cone anglesare also possible. Other configurations of the distal tip of the needle104 are also possible. For example, the needle 104 may include sidewallapertures, apertures configured to spray fluid, etc. The needle 104comprises a needle lumen 320 configured to be in fluid communicationwith a drug delivery system, and fluid can be delivered out of the tipof the needle 104.

In some embodiments, a method of manufacturing the endoluminal drugdelivery device 100 comprises inserting the needle 104 into the secondlumen 318 of the catheter 102. In some embodiments, the method ofmanufacturing comprises shape setting (e.g., heat setting) the distalportion of the needle 104 into a curved or other configuration. In someembodiments, the method of manufacturing comprises shaping the distaltip of the needle 104 into a beveled or pencil point tip (e.g., by lasercutting, grinding, chemical etching, etc.).

In some embodiments, for example as shown in FIG. 2, the second lumen318 optionally comprises (e.g., is at least partially lined with) aguide tube 314. The guide tube 314 can comprise (e.g., be made of), forexample, 304 stainless steel hypodermic tubing. Other materials are alsopossible. The distal end of the guide tube 314 can comprise a modifiedTuohy-style tip with a radius between about 0.47 in. and about 0.53 in.(approx. between about 1.19 cm and about 1.35 cm). Other radii ofTuohy-style tips of the guide tube 314 are also possible, for examplebased on the shape of the distal portion of the needle 104, catheterdimensions, etc. A Tuohy-style distal tip of the guide tube 314 can besubstantially aligned with the exit port 106 so that the needle 104 canexit the guide tube 314 and the catheter 102 through the exit port 106as described in greater detail herein. The Tuohy-style tip of the guidetube 314 can serve as a deflection surface (e.g., as described herein)for the needle 104 to protect the interior of the catheter 102 as theneedle 104 exits the catheter 102 through the exit port 106. In someembodiments, the guide tube 314 can be 20 gauge and have an outsidecross-sectional diameter between about 0.03 in. and about 0.4 in.(approx. between about 0.076 cm and about 0.102 cm) and an insidecross-sectional diameter between about 0.025 in. and about 0.035 in.(approx. between about 0.064 cm and about 0.089 cm). Other dimensions ofthe guide tube 314 are also possible, for example based on dimensions ofthe needle 104, dimensions of the catheter 102, etc. In someembodiments, the guide tube 314 is adhered to the interior wall of thesecond lumen 318. In some embodiments, the guide tube 314 is insertedinto the second lumen 318. In certain such embodiments, the shape of theguide tube 314 causes the guide tube 314 to remain properly positionedwithin the lumen 318. In some embodiments, the guide tube 314 extendsfrom the proximal end 115 to the exit port 106. In certain suchembodiments, the guide tube 314 can have a length of about 22 in.±about0.03 in. (approx. about 56 cm±about 0.076 cm). In some embodiments, onlya portion, for example, about 0.5 in. to about 1.5 in. (approx. about1.3 cm to about 3.8 cm) of the second lumen 318 proximate to the exitport 106 comprises a guide tube 314. Other lengths of the guide tube 314are also possible (e.g., corresponding to the length of a straighteneddistal portion of the needle 104).

In some embodiments, the guide tube 314 is cut (e.g., laser cut) tomaintain the flexibility of the catheter 102. The guide tube 314 canadvantageously add strength to the catheter 102, inhibiting (e.g.,preventing) torque, deformation of the distal portion 200 that may becaused by the curved shape of the distal portion of the needle 104,and/or skiving or other damage near the exit port 106 caused by theneedle 104. The guide tube 314 may also beneficially keep the curveddistal portion of the needle 104 straight while the distal portion ofthe needle 104 is inside the catheter 102 and/or allow the needle 104 tomove more freely within the catheter 102 as compared to movement of aneedle 104 in a plastic, which may for example soften if heated to bodytemperature. In some embodiments, a method of manufacturing anendoluminal drug delivery device 100 comprises inserting the guide tube314 into the second lumen 318. In some embodiments, a method ofmanufacturing the device 100 comprises cutting (e.g., laser cutting)and/or shaping the guide tube 314. Other support structures (e.g., acoil, a braid) are also possible to have some of the advantagesdescribed herein.

In some embodiments, the device 100 optionally includes a catheter lumensplitter or Y-connector 108 coupled to the catheter 102 proximate to theproximal end 115 of the catheter 102. In some embodiments, a method ofmanufacturing an endoluminal drug delivery device 100 comprises couplinga lumen splitter 108 to the catheter 102. In some embodiments, thesplitter 108 has a length between about 1 in. and about 2 in. (approx.between about 2.5 cm and about 5.0 cm). Other lengths are also possible(e.g., depending on the dimensions of the catheter 102, the amount ofsplit desired, etc.). In some embodiments, the splitter 108 compriseshigh density polyethylene (HDPE). Other materials are also possible. Insome embodiments, the splitter 108 comprises a first lumen 516 and asecond lumen 518. In some embodiments, the first and second lumens 516,518 of the splitter 108 converge toward the distal end of the splitter108 to form a single lumen. In some embodiments, for example as shown inFIG. 5A, as the catheter 102 passes through the lumen splitter 108 froma distal end of the lumen splitter 108 to a proximal end of the lumensplitter 108, the catheter 102 separates into two single lumencomponents. The splitter 108 may advantageously provide strength at thejoint where the catheter 102 separates. In some embodiments, a portionof the catheter 102 comprising the first lumen 316 passes through thefirst lumen 516 of the splitter 108 and extends beyond the proximal endof the lumen splitter 108 by about 4.5 in. to about 5.5 in. (approx.about 11.4 cm to about 14 cm). In some embodiments, a proximal end ofthe portion of the catheter 102 comprising the first lumen 316 comprisesa fitting, for example a Luer fitting (e.g., as illustrated in FIG. 1).In some embodiments, the portion of the catheter 102 comprising thefirst lumen 316 does not extend beyond the proximal end of the lumensplitter 108, and the proximal end of the splitter 108 comprises afitting, for example a Luer fitting.

In some embodiments, the needle 104 and a portion of the catheter 102comprising the second lumen 318 pass through the second lumen 518 of thesplitter 108 and extend about 3 in. (approx. about 7.6 cm) beyond theproximal end of the splitter 108, for example for coupling to ahandpiece assembly 120. In some embodiments, the guide tube 314 can alsopass through the second lumen 518 of the splitter 108 and extend beyondthe proximal end of the splitter 108, for example for coupling to ahandpiece assembly 120. In some embodiments, for example as shown inFIG. 5B, the guide tube 314 terminates within the splitter 108 and doesnot extend beyond the proximal end of the splitter 108. In someembodiments, for example as shown in FIG. 5B, the portion of thecatheter 102 comprising the second lumen 318 terminates within thesplitter 108. In certain embodiments, a separate piece of cathetertubing 520 may optionally be attached (e.g., welded, glued, adhered,mechanically crimped, mechanically swaged, combinations thereof, and thelike) to the proximal end of the splitter 108 in fluid communicationwith the second lumen 518 of the splitter 108 and surrounding the needle104. In some embodiments, a method of manufacturing comprises attaching(e.g., welding, gluing, adhering, mechanically crimping, mechanicallyswaging, combinations thereof, and the like) a separate piece ofcatheter tubing 520 to the proximal end of the splitter 108 in fluidcommunication with the second lumen 518 of the splitter 108 andsurrounding the needle 104.

The lumens 516, 518 of the splitter 108 and/or proximal sections of theneedle 104, guide tube 314, and/or catheter 102 can be configured toangle away from the longitudinal axis of the catheter 102. For example,a proximal portion of the portion of the catheter 102 comprising thefirst lumen 316 can angle away from the longitudinal axis of thecatheter 102 in a first direction at an angle β to spatially separatethe first lumen 316 of the catheter 102 from the second lumen 318 of thecatheter 102 and/or to allow easier manipulation of a guidewire in thefirst lumen 316 of the catheter 102. In some embodiments, the angle β isbetween about 10° and about 30°, between about 15° and about 25° (e.g.,about 20°), combinations thereof, and the like. Other angles β are alsopossible, for example depending on the guidewire to be used (e.g.,amount of manipulation room preferred for a guidewire, maximum bendingangle for a guidewire, etc.). For another example, proximal portions ofthe second lumen 518 of the splitter 108, needle 104, guide tube 314,and/or portion of the catheter 102 comprising the second lumen 318 canangle away from the longitudinal axis of the catheter 102 in a seconddirection (e.g., opposite to the first direction) at an angle γ tospatially separate the first lumen 316 of the catheter 102 from thesecond lumen 318 of the catheter 102 and/or to allow easier manipulationof a handpiece assembly 120. In some embodiments, the angle .gamma. isbetween about 10° and about 30°, between about 15° and about 25° (e.g.,about 20°), combinations thereof, and the like. Other angles .gamma. arealso possible, for example depending on the handpiece assembly 120 to beused (e.g., amount of manipulation room preferred for the handpieceassembly 120), the needle 104 (e.g., maximum bending angle for theneedle 104), etc. Separation of the first and second lumens 316, 318 ofthe catheter 102 may advantageously allow for improved maneuverabilityof the various components of the device 100 during use.

In some embodiments, the endoluminal drug delivery device 100 optionallyincludes a handpiece assembly 120. FIG. 6A shows an exploded view of thehandpiece assembly 120, and FIG. 6B shows a longitudinal cross-sectionalview of the assembled handpiece assembly 120. The handpiece assembly 120comprises a handle 110, a driver 630, and a button 620. The handle 110can be coupled to the proximal end of the portion of the catheter 102comprising the second lumen 318, for example extending proximal to alumen splitter 108 as shown in FIG. 5A or otherwise. In someembodiments, the handle 110 is coupled to a separate piece of cathetertubing 520 attached to the proximal end of a splitter 108 in fluidcommunication with the second lumen 518 of the splitter 108 as shown inFIG. 5B. Other connections are also possible (e.g., embodiments in whichthe device 100 does not comprise a lumen splitter 108). In someembodiments, the handle 110 is coupled to the guide tube 314. In someembodiments, the handle 110 is coupled to or integrated with a splitter108. The handle 110 may optionally comprise a separate distal piece ornose 640 that is attached (e.g., welded, glued, adhered, mechanicallycrimped, mechanically swaged, combinations thereof, and the like) to themain body 642 of the handle 110. In some embodiments, the nose 640 isintegral with the main body 642 of the handle 110 and is not a separatecomponent. Constructing the handle 110 with a separate nose 640 mayadvantageously allow for easier manufacturing and/or assembly of thehandpiece assembly 120, allow rotation (e.g., ratcheting) of the needle104 relative to the catheter 102, etc. Constructing the handle 110 withthe nose 640 integral to the main body 642 may advantageously reduce thenumber of pieces, reduce assembly complexity, and/or reduce thelikelihood of the pieces separating during use.

When assembled, the driver 630 of the handpiece assembly 120 is insidethe handle 110. The button 620 is inserted into a cutout 650 in the topof the handle 110 and snaps into a notch 652 in the top of the driver630. Other connections between the button 620 and the driver 630 arealso possible (e.g., adhering). The proximal end of the needle 104 isattached to the distal end of the driver 630, for example with adhesive(e.g., Class VI epoxy), over molding, and/or other coupling techniques.The driver 630 translates movement of the button 620 into movement ofthe needle 104. The button 620 is used to distally longitudinally extendand proximally longitudinally retract the needle 104 within the catheter102, and to cause the needle 104 to extend out of the exit port 106 andto retract into the exit port 106. In some embodiments, the needle 104is rotationally fixed relative to the catheter 102, for example due tothe catheter 102 being fixed to the lumen splitter 108 and handle 110.In some embodiments, the button 620 slides in a track 660 andlongitudinal movement of the button 620 causes 1:1 longitudinal movementof the needle 104 within the second lumen 318 of the catheter 102. Insome embodiments, no handpiece assembly 120 is used, and instead theproximal end of the needle 104 is directly manipulated.

In some embodiments, a method of manufacturing the device 100 includesassembling the handpiece assembly 120 and coupling the handpieceassembly 120 to the device 100. For example, the driver 630 may beplaced in the distal end of the handle 110 and rotated until the notchis aligned with the cutout 650. The driver 630 may then be coupled tothe button 620 and the needle 104. In some embodiments, a method ofmanufacturing comprises coupling the handpiece assembly 120 (e.g., thehandle 110 or the nose 640 of the handle 110) to the catheter 102, thelumen splitter 108, a tube 520, etc.

In some embodiments, an endoluminal drug delivery system comprises theendoluminal drug delivery device 100 and tubing 644 configured tofluidly couple the needle lumen to a drug delivery system. The distalend of the tubing 644 can be coupled to the proximal end of the driver630 in the handle 110, for example via a Luer fitting, a barb setting(e.g., as illustrated in FIG. 6B), etc., and the proximal end of thetubing 644 can be coupled to the drug delivery system. The tubing cancomprise, for example, PVC tubing. The tubing may comprise a flexiblematerial so that the movement of the needle 104 does not necessarilycause movement of the drug delivery system.

FIGS. 7A and 7B illustrate an example embodiment of a drug deliverysystem 700 comprising a bi-directional valve 740 coupled to the proximalend of the tubing 644 via a barb (other coupling techniques (e.g., aLuer fitting) are also possible), a syringe 742, and a drug source 744.In some embodiments, the valve 740 comprises a DCV Series double checkvalve available from Value Plastics®, Inc. of Fort Collins, Colo. Thevalve 740 can comprise three ports: a chimney port 746 configured to beconnected to the fluid supply vessel or drug source 744, an aspirationport 748 configured to be connected to the syringe 742, and a fluid exitport 750 configured to be connected to the tubing 644. The tubing 644connects the fluid exit port 750 of the valve 740 to the needle 104 ordriver 630.

To deliver fluid to the needle lumen and thus to the target tissue,first the plunger of the syringe 742 is pulled back, causing fluid to bedrawn from the fluid supply 744 through the chimney port 746, throughthe aspiration port 748, and then into the syringe 742, as shown in FIG.7A. The valve to the fluid exit port 750 is pressurized so that fluid(e.g., blood) does not flow from the tubing 644 into the syringe 742.When the plunger of the syringe 742 is then pushed forward, the valve tothe chimney port 746 is pressurized so that the fluid cannot travel backthrough the chimney port 746, and fluid is expelled through the fluidexit port 750 as shown in FIG. 7B.

In some embodiments, the drug delivery system comprises a pump connectedto a drug source. In certain such embodiments, the pump is configured toapply positive pressure or zero pressure so that fluid (e.g., blood)does not flow from the needle 104 into the drug source. Other drugsupply systems are also possible. The various components of the drugsupply system can be connected to each other and the needle or drivervia Luer fittings or other appropriate fittings.

Method of Delivering Fluid to Tissue

FIG. 8 shows an example embodiment of a method of delivering a fluid totissue 960 surrounding a body lumen 970. The method can be performedusing an endoluminal drug delivery device 100 and a drug delivery system700 as described herein. According to some embodiments of the method, aguidewire 950 is percutaneously inserted into the body lumen 970 throughthe body lumen wall 972, for example, into a varicose or insufficientvein just below the knee. The proximal end of the guidewire 950 isinserted into the opening 112 of the catheter 102, and the distal end116 of the device 100 is inserted into the body lumen 970 by trackingthe first lumen 316 of the catheter 102 over the guidewire 950. When theexit port 106 of the catheter 102 is in a first position, the button 620on the handpiece assembly 120 outside the body is actuated to cause thedistal portion of the needle 104 to exit the catheter 102 through theexit port 106. The needle 104 continues through the body lumen wall 972and into the target tissue 960. If there is no handpiece assembly 120,the needle 104 is directly manipulated to cause the distal portion ofthe needle 104 to exit the catheter 102 through the exit port 106 andcontinue through the body lumen wall 972 into the target tissue 960. Asyringe 742 or pump is operated to deliver the drug to the tissue 960.The button 620 on the handpiece assembly 120 is actuated or the needle104 is directly manipulated to retract the needle 104 back into thecatheter 102.

In some embodiments of the method, the device 100 is then again trackedover the guidewire 950 until the exit port 106 is in a second position.The button 620 on the handpiece assembly 120 is again actuated or theneedle 104 is directly manipulated to cause the distal portion of theneedle 104 to exit the catheter 102 through the exit port 106 andcontinue through the body lumen wall 972 and into the target tissue 960.The syringe 742 or pump is again operated to deliver the drug to thetissue 960, and the needle 104 is retracted back into the catheter 102.The foregoing process can be repeated for a desired number of positions.

In some embodiments, a method of delivering fluid to tissue can beperformed using an endoluminal drug delivery device 100 with multipleexit ports 106 a-106 n, as described herein and illustrated in FIG. 3C.Similarly to the method using a single exit port device, a guidewire 950is percutaneously inserted into the body lumen 970, and the device 100is inserted into the body lumen 970 by tracking the first lumen 316 ofthe catheter 102 over the guidewire 950. When the device is insertedinto the body lumen 970, the needle 104 is positioned within thecatheter such that the distal end of the needle 104 is between the mostdistal exit port 106 a and the second exit port 106 b from the distalend 116 of the catheter 102.

Once the catheter 102 is positioned within the body lumen 970, thebutton 620 on the handpiece assembly 120 outside the body is actuated tocause the distal end of the needle 104 to exit the catheter 102 throughthe most distal exit port 106 a. The needle 104 continues through thebody lumen wall 972 and into the target tissue 960. Alternatively, ifthere is no handpiece assembly 120, the needle 104 is directlymanipulated to cause the distal end to exit through the most distal exitport 106 a and continue through the body lumen wall 972 into the targettissue 960. A syringe 742 or pump is operated to deliver the drug to thetissue 960. The button 620 on the handpiece assembly 120 is actuated orthe needle 104 is directly manipulated to retract the needle 104 backinto the catheter 102. The catheter 102 is then held stationary withinthe body lumen, and the needle 104 is moved proximally within the secondlumen 318 until the needle 104 exits the second exit port 106 b from thedistal end 116 of the catheter 102. If the device 100 comprisesadditional exit ports 106, this process can be repeated.

The method of delivering a fluid to tissue surrounding a body lumen 970can be used, for example, to deliver numbing medication to an area oftissue surrounding a target vein prior to laser or RF ablation treatmentfor varicose or insufficient veins. In some embodiments, the method oftreatment further comprises performing the ablation. The fluid maycomprise a drug or anesthetic such as tumescent, which can be, forexample, lidocaine possibly in combination with epinephrine, althoughthe exact drug and composition can vary by hospital, provider, patient,and/or treatment.

Although this disclosure has been described in the context of certainembodiments and examples, it will be understood by those skilled in theart that the disclosure extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses and obviousmodifications and equivalents thereof. In addition, while severalvariations of the embodiments of the disclosure have been shown anddescribed in detail, other modifications, which are within the scope ofthis disclosure, will be readily apparent to those of skill in the art.It is also contemplated that various combinations or sub-combinations ofthe specific features and aspects of the embodiments may be made andstill fall within the scope of the disclosure. It should be understoodthat various features and aspects of the disclosed embodiments can becombined with, or substituted for, one another in order to form varyingmodes of the embodiments of the disclosure. Furthermore, dimensions ofvarious components provided herein are exemplary, and other dimensionsmay be used. Thus, it is intended that the scope of the disclosureherein should not be limited by the particular embodiments describedabove.

What is claimed is:
 1. A method of delivering a fluid to tissuesurrounding a body lumen having a wall, the method comprising:percutaneously inserting a guidewire into the body lumen through thewall; inserting a distal end of an endoluminal drug delivery device intothe body lumen by tracking a first lumen of the device over theguidewire, the device comprising: a catheter having a proximal end and adistal end; the first lumen extending from the proximal end to thedistal end; a second lumen extending between the proximal end and anexit port, a section of the catheter distal to the exit port beingself-dilating during tracking; and a needle configured to bias away fromthe second lumen and out of the exit port when the needle islongitudinally distally advanced; when the exit port is in a firstposition advancing the needle out of the second lumen through the exitport; advancing the needle through the wall to the tissue; deliveringthe fluid to the tissue through the needle; and retracting the needleinto the catheter.
 2. The method of claim 1, further comprising:tracking the device over the guidewire within the body lumen; when theexit port is in a second position advancing the needle out of the secondlumen through the exit port; advancing the needle through the wall tothe tissue; delivering the fluid to the tissue through the needle; andretracting the needle into the catheter.
 3. The method of claim 1,wherein the fluid comprises tumescent.
 4. The method of claim 1, whereinthe body lumen is an insufficient vein.
 5. The method of claim 1,further comprising treating the body lumen with laser or radio frequencyablation.
 6. An endoluminal drug delivery device comprising: a flexiblecatheter having a proximal end and a distal end; a first lumen extendingfrom the proximal end to the distal end and configured to house aguidewire; a second lumen extending between the proximal end and an exitport, a section of the catheter distal to the exit port beingself-dilating; and a needle configured to bias out of the exit port andaway from the second lumen when the needle is longitudinally distallyadvanced, the needle including a needle lumen configured to be in fluidcommunication with a drug delivery system.
 7. The device of claim 6,wherein the exit port is proximate to the distal end.
 8. The device ofclaim 6, wherein a distal portion of the catheter comprises a taper atleast partially defined by a decrease in an outer diameter of thecatheter from a proximal end of the taper to the distal end of thecatheter.
 9. The device of claim 6, wherein the catheter comprises adeflection surface.
 10. The device of claim 6, further comprising alumen splitter coupled to the catheter proximate to the proximal end ofthe catheter.
 11. The device of claim 6, further comprising a handpieceassembly coupled to a proximal end of the device, the handpiece assemblycomprising a button coupled to the needle, wherein actuation of thebutton causes relative longitudinal movement between the needle and thecatheter.
 12. The device of claim 11, wherein longitudinal movement ofthe button causes 1:1 longitudinal movement of the needle in the secondlumen.
 13. The device of claim 6, wherein the needle is rotationallyfixed relative to the catheter.
 14. The device of claim 6, wherein thecatheter comprises polyethylene.
 15. The device of claim 6, wherein thecatheter has a length between about 45 cm and about 55 cm.
 16. Thedevice of claim 6, wherein a portion of the second lumen proximate tothe exit port comprises a rigid lining.
 17. The device of claim 6,wherein the needle comprises a shape memory material.
 18. The device ofclaim 17, wherein the needle comprises nitinol.
 19. The device of claim6, wherein a distal portion of the needle is curved when at leastpartially outside the second lumen.
 20. The device of claim 6, whereinthe needle comprises a beveled distal tip.
 21. An endoluminal drugdelivery system comprising: the device of claim 6; and tubing configuredto couple the needle lumen to a drug delivery system.
 22. The system ofclaim 21, wherein the drug delivery system comprises a dual check valveconfigured to be connected to a fluid source and a syringe.
 23. Thesystem of claim 21, wherein the drug delivery system comprises a pumpconfigured to be connected to a fluid source.
 24. A method ofmanufacturing an endoluminal drug delivery device, the methodcomprising: inserting a needle into a second lumen of a cathetercomprising: a first lumen extending from a proximal end to a distal endand configured to house a guidewire; and the second lumen extendingbetween the proximal end and an exit port, a section of the catheterdistal to the exit port being self-dilating; the needle configured tobias out of the exit port and away from the second lumen when the needleis longitudinally distally advanced, the needle including a needle lumenconfigured to be in fluid communication with a drug delivery system. 25.The method of claim 24, further comprising inserting a guide tube intothe second lumen, the guide tube surrounding the needle.
 26. The methodof claim 24, further comprising coupling a lumen splitter to thecatheter proximate to the proximal end of the catheter.
 27. The methodof claim 24, further comprising connecting a handpiece assembly to aproximal end of the device.
 28. The method of claim 27, wherein thehandpiece assembly comprises a driver and wherein connecting thehandpiece assembly to the proximal end of the device comprisesconnecting a proximal end of the needle to a distal end of the driver.29. The method of claim 24, further comprising forming a distal end ofthe needle into a beveled tip.
 30. The method of claim 24, furthercomprising shape setting a distal portion of the needle into a curvedconfiguration.